Hand-held Dental X-ray System (HyperLight-M)
K-Number: K260795 · 2026-09-14
Device Summary
Frequently Asked Questions
What is the Hand-held Dental X-ray System (HyperLight-M)?
Hand-held Dental X-ray System (HyperLight-M) is a medical device that received FDA 510(k) clearance on 2026-09-14. The listed applicant is Changzhou Sifary Medical Technology Co., Ltd.. The 510(k) number is K260795.
When did Hand-held Dental X-ray System (HyperLight-M) receive FDA 510(k) clearance?
Hand-held Dental X-ray System (HyperLight-M) received FDA 510(k) clearance on 2026-09-14, under 510(k) number K260795.
Who is the listed applicant for Hand-held Dental X-ray System (HyperLight-M)?
The FDA 510(k) record lists Changzhou Sifary Medical Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Hand-held Dental X-ray System (HyperLight-M)?
The FDA product code for Hand-held Dental X-ray System (HyperLight-M) is EHD.
Other records listing Changzhou Sifary Medical Technology Co., Ltd. as applicant
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
Related Devices (Code: EHD)
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.